Savara Reports First Quarter 2021 Financial Results and Provides Business Update
Savara Inc. (Nasdaq: SVRA) reported a net loss of $10.2 million or $(0.13) per share for Q1 2021, an improvement from a loss of $15.4 million or $(0.27) per share in Q1 2020. The company reduced R&D expenses by 42.5% to $7.6 million, mainly due to the absence of costs related to the acquisition of Apulmiq. Savara raised $130 million in equity, enhancing its cash position to approximately $193 million, expected to fund operations through 2025. The IMPALA-2 trial's site activation is underway, with early patient randomization anticipated by late Q2 or early Q3 2021.
- Reduced net loss to $10.2 million in Q1 2021, improved from $15.4 million in Q1 2020.
- R&D expenses decreased by 42.5%, totaling $7.6 million.
- Successful $130 million equity raise, strengthening cash position to approximately $193 million.
- Estimated cash runway extended through 2025.
- None.
Savara Inc. (Nasdaq: SVRA), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today reported financial results for the first quarter ending March 31, 2021 and provided a business update.
“We made considerable progress in the first quarter of the year,” said Matt Pauls, Chair and Chief Executive Officer, Savara. “This includes the strategic decision to wind down two pipeline programs, enabling us to focus solely on advancing our lead asset, molgramostim in aPAP. Additionally, we started the onboarding process of a global, full-service contract research organization that is partnering with us to execute the IMPALA-2 trial. Lastly, we strengthened our cash position through a
“We are pleased to announce that the IMPALA-2 site activation process has begun,” said Badrul Chowdhury, Chief Medical Officer, Savara. “Sites will be activated on a rolling basis, with approximately 10-15 expected to be active by the end of June. As sites launch, patients are evaluated, and those who are eligible will begin a six-week screening period. This means patients could be randomized and dosed by the end of 2Q or early 3Q 2021. We also recently strengthened our management team with the hire of Dr. Dhaval Desai as Head of Clinical Development and Brian Maurer as Head of Clinical Operations. Both are seasoned professionals with deep expertise in running global clinical trials.”
First Quarter Financial Results (Unaudited)
Savara’s net loss attributable to common stockholders for the three months ended March 31, 2021 was
Research and development expenses decreased by
General and administrative expenses decreased by approximately
As of March 31, 2021, Savara had cash, cash equivalents, and short-term investments of approximately
About Savara
Savara is a clinical stage biopharmaceutical company focused on rare respiratory diseases. Our lead program, molgramostim nebulizer solution, is an inhaled granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (aPAP). Our management team has significant experience in rare respiratory diseases and pulmonary medicine, identifying unmet needs, and effectively advancing product candidates to approval and commercialization. More information can be found at www.savarapharma.com. (Twitter: @SavaraPharma, LinkedIn: www.linkedin.com/company/savara-pharmaceuticals/).
Forward Looking Statements
Savara cautions you that statements in this press release that are not a description of historical fact are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words referencing future events or circumstances such as “expect,” “intend,” “plan,” “anticipate,” “believe,” and “will,” among others. Such statements include, but are not limited to, our belief our cash runway extends through 2025; the expected timing of top line results of IMPALA-2 in Q2 2024; that trial sites will be activated on a rolling basis; that approximately 10-15 trial sites are expected to be active by the end of June; and that patients could be randomized and dosed by the end of 2Q or early 3Q 2021. Savara may not actually achieve any of the matters referred to in such forward-looking statements, and you should not place undue reliance on these forward-looking statements. These forward-looking statements are based upon Savara’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the risks and uncertainties relating to the impact of the COVID-19 pandemic on our business and operations, the outcome of our ongoing and planned clinical trials for our product candidates, the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient resources for Savara’s operations and to conduct or continue planned clinical development programs, the ability to obtain the necessary patient enrollment for our product candidates in a timely manner, the ability to successfully develop our product candidates, the risks associated with the process of developing, obtaining regulatory approval for and commercializing drug candidates such as molgramostim that are safe and effective for use as human therapeutics, and the timing and ability of Savara to raise additional capital as needed to fund continued operations. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of our risks and uncertainties, you are encouraged to review our documents filed with the SEC including our recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Savara undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as may be required by law.
| Savara Inc. and Subsidiaries | |||||||||
| Condensed Consolidated Statements of Operations and Comprehensive Loss | |||||||||
| (in thousands, except for share and per share amounts) | |||||||||
| (Unaudited) | |||||||||
| Three months ended | |||||||||
| March 31, | |||||||||
|
2021 |
|
|
2020 |
|
||||
| Operating expenses: | |||||||||
| Research and development | $ |
7,589 |
|
$ |
13,200 |
|
|||
| General and administration |
|
2,778 |
|
|
2,982 |
|
|||
| Depreciation and amortization |
|
47 |
|
|
58 |
|
|||
| Total operating expenses |
|
10,414 |
|
|
16,240 |
|
|||
| Loss from operations | $ |
(10,414 |
) |
$ |
(16,240 |
) |
|||
| Other income, net |
|
197 |
|
|
819 |
|
|||
| Net loss attributable to common stockholders | $ |
(10,217 |
) |
$ |
(15,421 |
) |
|||
| Net loss per share - basic and diluted | $ |
(0.13 |
) |
$ |
(0.27 |
) |
|||
| Weighted average shares - basic and diluted |
|
76,992,407 |
|
|
57,364,265 |
|
|||
| Other comprehensive loss |
|
(457 |
) |
|
(111 |
) |
|||
| Total comprehensive loss | $ |
(10,674 |
) |
$ |
(15,532 |
) |
|||
| Savara Inc. and Subsidiaries | ||||||
| Condensed Consolidated Balance Sheet Data | ||||||
| (in thousands) | ||||||
| (Unaudited) | ||||||
March 31, |
|
December 31, |
||||
2021 |
|
2020 |
||||
| Cash, cash equivalents, and short-term investments | $ |
192,713 |
$ |
82,188 |
||
| Working capital |
|
187,595 |
|
76,947 |
||
| Total assets |
|
207,630 |
|
97,745 |
||
| Total liabilities |
|
32,509 |
|
33,362 |
||
| Stockholders' equity |
|
175,121 |
|
64,383 |
||
View source version on businesswire.com: https://www.businesswire.com/news/home/20210513005857/en/
FAQ
What were Savara's financial results for Q1 2021?
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